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Trial record 121 of 242 for:    Recruiting, Not yet recruiting, Available Studies | "Hypertension, Pulmonary"

Acute Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT03365479
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Jan Grimminger, University of Giessen

Brief Summary:

Primary objective

• To evaluate the effect of rapid inhalation of 2.5μgiloprost using the Breelib nebulizer on pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension

Secondary objectives

  • To evaluate the effect of rapid iloprost inhalation using the Breelib nebulizer on mean pulmonary arterial pressure (mPAP), cardiac output (CO), cardiac index (CI), systemic blood pressure, arterial oxygen saturation, heart rate, and pulmonary arterial wedge pressure (PAWP).
  • To evaluate the safety and tolerability of the rapid iloprost inhalation using the Breelib nebulizer.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Pulmonary Arterial Hypertension Drug: Iloprost Not Applicable

Detailed Description:

This study aims to investigate the acute hemodynamic and pharmacological effects of a single inhalation of Iloprost (2.5μg) during right heart catheterization (RHC) using the Breelib nebulizer. Patients with confirmed diagnosis of pulmonary arterial hypertension (PAH = WHO group 1), NYHA functional class III and with stable background pulmonary vasoactive treatment or treatment naïve PAH patients will be challenged with the iloprost inhalation dosage during RHC. As a proof-of concept design, the study will include consecutive PAH patients only challenged with a single administration of inhaled iloprost 2.5 μg delivered via Breelib nebulizer during right heart catheterization (day 2).

The acute hemodynamic response will be followed over 30 minutes. Change of pulmonary hemodynamics, systemic blood pressure, right ventricular echocardiographic parameters and adverse events will be assessed at baseline and 5, 10, 15, 30 minutes after the end of inhalation.

Recently, the Breelib nebulizer has been evaluated within a multicenter, randomized, unblinded, study. This safety and feasibility study compared inhalation time, pharmacokinetics, and acute tolerability of inhaled iloprost delivered via Breelib versus the standard I-Neb nebulizer. The primary safety endpoints (AEs) were reported with a low frequency and were consistent with the known safety profile of iloprost. Median inhalation times were considerably shorter while maximum iloprost plasma concentration and systemic exposure were significantly higher, with Breelib versus I-Neb. Previously, it was shown that the acute hemodynamic response of iloprost inhalation via the previous used I-Neb nebulizer resulted in a relevant and significant reduction of PVR and increase in CI. Moreover, previous generation of nebulizers also resulted in a significant reduction of PVR and increase in CI 5-15min after iloprost inhalation.

Therefore, the aim of the current study is to determine the acute hemodynamic effects on the pulmonary and the systemic circulation as well as on the gas exchange of 2.5 μg iloprost delivered via the Breelib device. The investigators aim to characterize the hemodynamic profile of the inhalation with Breelib as the investigators speculate that the shortened inhalation time will result in an enhanced hemodynamic response with substantial reduction of pulmonary vascular resistance (PVR). Moreover, as a secondary outcome measurement the investigators aim to assess the response of mean pulmonary arterial pressure, cardiac index/cardiac output, systemic blood pressure, right ventricular echocardiographic parameters and oxygen saturation after inhalation of 2.5μg iloprost and analyze adverse events.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Acute Hemodynamic Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2019


Arm Intervention/treatment
Experimental: Study cohort
The study comprises a 1-day Screening period, followed by a right heart catheterization with a single administration of inhaled iloprost 2.5 μg delivered via Breelib nebulizer
Drug: Iloprost
Single administration of inhaled iloprost 2.5 μg delivered via Breelib nebulizer




Primary Outcome Measures :
  1. Change of PVR (∆PVR) [ Time Frame: 5, 10, 15, 30 minutes after the end of inhalation ]

Secondary Outcome Measures :
  1. Change of mPAP [ Time Frame: at baseline and 5, 10, 15, 30 minutes after the end of inhalation ]
  2. Change of PAWP [ Time Frame: at baseline and 5, 10, 15, 30 minutes after the end of inhalation ]
  3. Change of CI [ Time Frame: at baseline and 5, 10, 15, 30 minutes after the end of inhalation ]
  4. Change of systemic blood pressure [ Time Frame: 5, 10, 15, 30 minutes after the end of inhalation ]
  5. Change of oxygen saturation [ Time Frame: 5, 10, 15, 30 minutes after the end of inhalation ]
  6. Change of right heart echocardiography [ Time Frame: 5, 10, 15, 30 minutes after the end of inhalation ]
  7. Adverse events (AEs) [ Time Frame: 5, 10, 15, 30 minutes after the end of inhalation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of pulmonary arterial hypertension, WHO group 1 diagnosed according to current guidelines
  • New York Heart Association functional class III
  • mPAP ≥ 25 mmHg, PAWP ≤ 15 mmHg
  • Age ≥ 18 years; ≤ 85 years
  • planned right heart catheterization based on clinical grounds
  • Stable specific PAH medications other than prostanoids
  • Signed informed consent

Exclusion Criteria:

  • other etiologic groups of pulmonary hypertension (WHO group 2, 3, 4, 5)
  • Unstable or severe coronary artery disease (history of cardiac surgery, history of coronary intervention 2 years prior to inclusion), uncontrolled arterial hypertension, severe left ventricular hypertrophy, severe congenital or acquired valvular or myocardial disease, systolic blood pressure < 90 mmHg, heart rate of <55 or >105 beats·min−1 before inhalation
  • Progressive left heart failure History of severe ventricular arrhythmias
  • Pulmonary veno-occlusive disease
  • Transitory ischemic attack (TIA) or stroke ≤ 3months
  • Severe hepatic impairment (> CHILD B)
  • Severe, terminal renal impairment
  • Use of intravenous, subcutaneous or oral prostacyclin/IP receptor agonists
  • Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of results

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365479


Contacts
Contact: Manuel Richter, MD +4964198557043 manuel.richter@innere.med.uni-giessen.de

Locations
Germany
University Clinic Giessen and Marburg Recruiting
Giessen, Hesse, Germany, 35392
Contact: Heuser Sina    +4964198557043    pegasusstudy@gmx.net   
Contact: Henning Gall, PhD    +4964198556766    pegasusstudy@gmx.net   
Principal Investigator: Ardeschir Ghofrani, Prof.         
Sub-Investigator: Manuel Richter, MD         
Sub-Investigator: Natascha Sommer, PhD         
Sub-Investigator: Henning Gall, PhD         
Sub-Investigator: Khodr Tello, MD         
Sub-Investigator: Jan Grimminger, MD         
Kerckhoff-Klinik Not yet recruiting
Bad Nauheim, Germany
Contact: Andreas Rieth, MD    +49 60 32 99 60    a.rieth@kerckhoff-klinik.de   
Sponsors and Collaborators
University of Giessen

Responsible Party: Jan Grimminger, Study Chair: Ghofrani H. Ardeschir, Prof. Dr. University of Giessen, University of Giessen
ClinicalTrials.gov Identifier: NCT03365479     History of Changes
Other Study ID Numbers: V04_21112017
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jan Grimminger, University of Giessen:
pulmonary hypertension
iloprost
inhaled
breelib
nebulizer
pulmonary arterial hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents